Slide 1: The CardiAMP Heart Failure Trial: Efficacy Outcomes from Roll-In Phase
The CardiAMP Heart Failure Tri \ Efficacy Outcomes from Roll-In Phas: Peter V. Johnston!, Henricus J. Duckers?, Amish N. Raval’, Thomas D. Cook3, Jay H, Traverse4, \ William T. Abrahams, Peter A. Altman?, Carl J. Pepine® i, John3Hopkins University, Baltimore, MD, 2.Biocardia, Inc, San Carlos, CA, Sa
Slide 2: Disclosures
Disclosures P.V. Johnston: Consultant/Advisory Board;Modest; Biocardia, Inc. H.J. Duckers: Employment; Significant; BioCardia, Inc.Ownership Interest; Significant; BioCardia, Inc. A.N. Raval: Research Grant; Modest; BioCardia, Inc. T.D. Cook: Research Grant; Modest; BioCardia, Inc. J.H, Traverse: Co
Slide 3: CardiAMP-HF Study Rationale
CardiAMP-HF Study Rationale Stem cell therapy shows promise in experimental models of ischemic cardiomyopathy, but results from clinical trials are variable Potential reasons include: + Variable potency of autologous cells + Poor cell retention and survival following delivery + Sub-optimal dosing Th
Slide 4: Clinical Trial Design
Clinical Trial Design Prospective, randomized, blinded, sham-controlled multi-center clinical trial 250 patients + 10 patient “Roll-In” Cohort (open-label) Enrollment criteria + Ischemic cardiomyopathy with EF 20-40% NYHA Class II-III symptomatic CHF Optimal medical therapy +/- CRT Sufficient cell p
Slide 5: 1° Endpoint: Change in 6-Min Walk Distance
1°Endpoint: Change in 6-Min Walk Distance 7 Change in 6MWD Relative to Baseline 10 =0.36 80 7 0.06. *p=0.01 S 3 60 021 2 40 mo 20 = _ TAC HFT 414.3 m* 3months 6months 9 months 12 months Mean +/-SEM; n=10, except at 9 months, when n=9 Ps 8/10 patients had improved 6MWD at 12 months BIOCARD Eee oe eee
Slide 6: Clinical Assessment of Heart Failure Severity
Clinical Assessment of Heart Failure Severity Minnesota ving w Heart Failure Distribution NYHA Heart Failure Class 8 Questionnaire » om 2 2 2 3 CC —— |. #TAC HFT oe a 8 ~ 8» o g - a 3 Baseline a § tun aM os sense olerchorgoin pso0te “p-OUS7 —prooe putea sats Mean +/-SEM; n=10 for NYHA HF Class at 3
Slide 7: LV Function Assessment at 12 months
LV Function Assessment at 12 months Global LV Function Change in LV Function 35 = 8 32. ng p=0.18 = 32.9 ie S 30 3 ir aap etl s4 p=0.49 3 25 gs 2 = s Cf = 20 S Baseline 6Months 12 Months Baseline 6Months 12 Months Mean +/-SEM; n=10; Transthoracic echocardiograms assessed by blinded readers in Echo C
Slide 8: Decrease in Akinetic Wall Segments
Decrease in Akinetic Wall Segments Akinetic Wall Segments Change in Akinetic Wall Segments 3° 7 s S 6 g-1 > & o Ey ® > a 4 g p=0.08 8 2 22 $3 *p=0.04 s 3 Zo - Baseline Months 12 Months Baseline 6Months = 12 Months + Mean +/SEM; n=10; Transthoracic Echocardiograms assessed by blinded readers in Echo
Slide 9: Improvement in Wall Motion Score
Improvement in Wall Motion Score Total Wall Motion Change in Wall Motion Score 8 40 ° 0 3 36.5 8 2 5° 30.6 a 3 5 3 20 3 *p=0.01 3 = 6 310 as 5 a. *p=0.01 3 -10 Baseline 6Months 12 Months Baseline 6Months 12 Months + Mean +/-SEM; n=10; Transthoracic Echocardiograms assessed by blinded readers in Echo
Slide 10: Summary
Summary 12-month Results from CardiAMP-HF Roll-In Phase Show: + Improved 6MWD at 6 mos (p=0.01); borderline at 12 mos (p=0.06) + Trends for improved NYHA HF Class and MLWHFQ Score + Recruitment of akinetic wall segments and improved wall motion at 12 mos + Low MACE (0 treatment related, 1 f/u MACE e
Slide 11: Acknowledgements
Acknowledgements = Roll-in phase of the CardiAMP HF Trial = John Hopkins University, Baltimore, MD = BioCardia, San Carlos, CA * Peter Johnston, * Valerie Nguyen * Gary Gerstenblith * Debby Holmes-Higgin = Jeffrey Brinker * Eduardo Tacdol * Ivan Borello * Ken Manley = Eric Duckers = University of Fl
Slide 12: Thank You!
q | .. THANK YOU! - I A BES Z